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PROPAFENONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS LTD · Approved 2017-09-08

Drug application

FDA Application #
ANDA205268
Application type
Abbreviated New Drug Application (Generic)
Brand name
PROPAFENONE HYDROCHLORIDE
Generic name
PROPAFENONE HYDROCHLORIDE
Active ingredients
PROPAFENONE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
GLENMARK PHARMS LTD
Manufacturer
Glenmark Pharmaceuticals Inc., USA
First approval
2017-09-08

Source

Authoritative
Drugs@FDA application overview
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